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Medical News and Perspectives
August 23/30, 2006

Report Criticizes Lack of FDA Oversight

JAMA. 2006;296(8):920-922. doi:10.1001/jama.296.8.920

A small cloud hovered over the June 30 celebration of the US Food and Drug Administration's (FDA) 100th anniversary in the form of a report, released 4 days earlier, that took the FDA to task for the agency’s lackluster enforcement of laws protecting the nation's food and medical products.

The report, issued by Rep Henry A. Waxman (D, Calif), said that during the past 5 years, the number of warning letters (a notice of violation of federal law) issued by the FDA to companies decreased by more than 50%. Waxman's report also said that officials at FDA headquarters routinely rejected the enforcement recommendations of the agency’s field staff and that the agency's recordkeeping and case tracking practices were inadequate.

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